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Centre acts against 34 pharma firms over substandard drugs
Central and state drugs regulators began conducting joint inspections earlier this year as part of a special drive to check production of substandard medicines
The Centre has taken action against at least 34 companies so far in the biggest crackdown against pharmaceutical companies manufacturing substandard drugs, according to people familiar with the matter.
The second round of inspections on this aspect is under way across the country. Central and state drugs regulators began conducting joint inspections earlier this year as part of a special drive to check production of substandard medicines in the country.
As part of this special drugs inspection drive, 203 pharmaceutical companies were identified for the joint inspection.
A majority of the companies are from Himachal Pradesh (which emerged a major pharma manufacturing hub last decade), followed by Uttarakhand, and Madhya Pradesh.
In the first phase, inspection was conducted of 76 pharma companies across 20 states, and 18 were reportedly found to be producing spurious and adulterated drugs.
According to the “action taken list by state licensing authorities”, a copy of which has been seen by HT, among the companies whose manufacturing licence was suspended or which were asked to stop production are included Himalaya Meditek Pvt Ltd registered in Dehradun, Sun AJ pharma, Indore (MP), Vintochem, Ujjain (MP), Om Biomedic, Haridwar (Uttarakhand), SVP Life Sciences, Dehradun, Uttarakhand, Apple Formulations, Roorkee, Uttarakhand, Relief Biotech, Roorkee, Uttarakhand, Agron Remedies, Kashipur, Uttarakhand, and Bajaj Formulations, Roorkee, Uttarakhand.
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HT reached out to the companies couldn’t elicit a response.
In addition, regulators issued show cause notices to Athens Life Sciences, Laborate Pharmaceuticals, Life Vision Healthcare, and JM Laboratories in Himachal Pradesh.
The 20 States where joint inspections were conducted are Andhra Pradesh, Bihar, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh, Jammu & Kashmir, Karnataka, Madhya Pradesh, Maharashtra, Puducherry, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttar Pradesh, Uttarkhand, and West Bengal.
According to people familiar with the matter, the joint inspections are a part of heightened pharma surveillance measures that the government decided to adopt after three incidents involving India-made products .
The Uttar Pradesh Drugs Controlling and Licensing Authority recently cancelled the manufacturing license of Noida-based pharmaceutical company, Marion Biotech, whose cough syrup was allegedly linked to the death of 18 children in Uzbekistan in December last year.
In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop allegedly linked to vision loss in the US.However, a joint inspection— with teams from central drugs standard control organization and state (Tamil Nadu) drugs regulator— was carried out at its manufacturing unit, and samples that were tested were found to be ‘free of contamination’, as per officials familiar with the matter.
And on October 5, WHO issued an alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharmaceuticals and likely linked to the deaths of 70 children in The Gambia.
While Haryana government’s investigation found violations in Maiden’s manufacturing processes, the samples tested of its drugs did not find any kind of contamination. The regulator, however, asked the company to stop manufacturing until investigation was completed
In February, the Union health ministry conducted a two day “Chintan Shivir” (deliberation camp) with focus on drugs quality, regulation, and enforcement. Steps are being taken to ensure harmonization of regulatory requirements, processes, and procedures as well as data bases across all States to ensure consistency in the evaluation and approval of drugs.
